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Completed

NCT Number: NCT02052284

The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

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Key information

Conditions

Fluid Loss Dehydration Extreme Immaturity Female Urogenital Diseases and Pregnancy Complications Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases Water-Electrolyte Imbalance

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University Hospital NICU

Washington D.C., District of Columbia, 20037, United States

About this study

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Extremely Low Birth Weight (less than 1000 grams at birth), and
  • Less than 24 hours of life

Exclusion criteria

  • Major congenital anomalies
  • Malformations or other surgical emergencies requiring immediate transfer.
  • Major skin abnormalities

Treatment and study plan

Sterile water application

Other

Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.

Primary outcomes

  1. Daily fluid intake (ml/kg/day)

    Time frame: First 7 days of life

    The primary outcome is daily fluid requirements in the first week of life. Daily fluid requirements from Day1 to Day7 will be compared between intervention and control groups.

Secondary outcomes

  1. Skin Score

    Time frame: First 7 days of life

    Neonatal Skin Condition Scale (NSCS) is a validated skin score used in the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the National Association of Neonatal Nurses (NANN) neonatal skin care evidence-based practice project. Score ranges from 3 to 9, with 9 being the worse

  2. Peak total bilirubin (mg/dl)

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

  3. Incidence of significant PDA

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

    Defined as PDA requiring treatment either medical or surgical

  4. Incidence of NEC

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

    Necrotizing Enterocolitis (NEC): defined as stages II or III

  5. Incidence of BPD

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

    Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)

  6. Length of stay (days)

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

  7. Incidence of culture proved sepsis

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

    Culture proved sepsis

  8. Incidence of change in microbiological skin colonization

    Time frame: First week of life

    Change in microbiological skin colonization by skin swab between day one and day 7 of life.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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